Development and Its Influence on Method Validation

The method development life cycle parallels established approaches to analytical method validation and computer validation.Clearly, analytical 

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Planning. Planning encompasses the user requirements of the method. Planning includes the following major items  

Goal All related substances must be chromatographically resolved from the active substance nothing should coelute with a specified related substance. Unspecified related substances could coelute with each other but must not coelute with the active, specified related substance or an excipient of the formulation. 

Method Development. Once the plan and resources are in place, the laboratory portion of the method development process can begin. For example, in the case of chromatographic method, after chromatographic parameters have been adjusted to enable proposed resolution of related substances in a reasonable analysis time, the methodology is assessed for the following  

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